Catalog Number

497302

Brand Name

Septishield II 80cm

Version/Model Number

497302

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K820883,K820883

Product Code

DYG

Product Code Name

Catheter, Flow Directed

Public Device Record Key

b80fc024-3a76-4f02-b732-95d727be1f66

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20886333214321

Quantity per Package

25

Contains DI Package

00886333214327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box